The reagent kit is a key element of a conventional and/or immunochemistry analytical system.
An analytical system is a machine for automatic execution of laboratory tests, requiring minimal intervention by the operator. Tests require preparation and dosage of biological samples and reagents, and identification thereof.
During the automatic test, fluids are mixed in the desired proportions, incubated, and analyzed as a function of the specific reaction involved. At the end of the measurements, the data are processed and presented by suitable software.
Reagents are the most important part of the system, because they allow to identify a wide range of composite analytes within biological fluids.
A reagent kit includes separate containers for a number of components, typically including diluents, reagents and calibrators.
A reagent kit is interchangeable, so that it can be replaced when exhausted or when the desired test type is changed. The kit is subject to autonomous production, transportation and storage (with respect to the analytical system). Each one of these stages has criticities due to potential content damage or alteration, depending on the desired quality and reliability of the measurements.
Therefore, for properly using the reagent kit, it is necessary to precisely identify it and be sure that it has been correctly stored and handled, so that it has not been subject to stresses that might have impaired its analytical performance.
For correctly managing the analytical system (reagent kit and instrument), it is also useful to have information about environmental events and about the presumed chemical-physical state of the reagents, so as to be able to find causes and take adequate corrective actions.
To ensure optimal performance, the man skilled in the art of developing analytical systems and reagent kits has to face a number of problems. Such problems require specific solutions for which it is de facto impossible to draw on other fields for usable technical knowledge.
Various types of sensors, as well as applications thereof in different technical fields, have been known for a long time. A passive or active RF-ID device is also per se known. The general notoriety of the above does not imply that they can obviously be used in the specific sector of developing an analytical system and a reagent kit.
For example, US2010/0180701-A1 describes a sensor device in the form of adhesive tape, to which different remote units are connected, each comprising one or more sensors, applicable in an adhesive manner to an object with a curved surface, such as a helmet, and electrically connected to a controller mounted on the adhesive tape itself. It is apparent that the system is not suitable for application within the technical scope of the present invention.